UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Title of the study (Brief title)	Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To do additional research on safety and efficacy of 88 patients enrolled in JUST-study, for further discussion of bi-weekly eribulin therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Time to Treatment Failure(TTF) of bi-weekly patients
Key secondary outcomes	Overall survival(OS), safety

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	All who enrolled in JUST-STUDY
Key exclusion criteria	none
Target sample size	88

Research contact person
Name of lead principal investigator	Shoichiro Ohtani
Organization	Hiroshima City Hospital
Division name	Breast Surgery
Address	7-33, Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL	082-22102291
Email	eriburlin-study@npo-acro.jp

Public contact
Name of contact person	JUST-STUDY Executive Office
Organization	NPO Advanced Clinical Reserch Organization
Division name	JUST-STUDY Executive Office
Address	2-10-3,kotobukicho,Fuchu,Tokyo
TEL	042-352-7676
Homepage URL
Email	eriburlin-study@npo-acro.jp

Sponsor
Institute	NPO Advanced Clinical Reserch Organization
Institute
Department

Funding Source
Organization	NPO Advanced Clinical Reserch Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 23 Day
Anticipated trial start date	2015 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	a

Management information
Registered date	2015 Year 09 Month 28 Day
Last modified on	2018 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022124